Replies to post #414936 on NorthWest Biotherapeutics Inc (NWBO)

[Bob_LobLaw]

"If we are subject to a standard review and have not yet submitted the application….incompetence."

I agree there is no way we have not begun the approval process if the trial results are strong. I would go further than incompetence given the patients lives being on the line.

I also have no faith in this management team being able to deliver a successful commercial launch. they must be working on a partnership at the least.

[Gus McCrae]

We do not know yet what steps have been taken regarding RA submission and approval. If we are subject to a standard review and have not yet submitted the application….incompetence. If we publish before presenting…incompetence. If we think we can hire and train a successful commercial operation ourselves in time to launch a blockbuster in 1H2022…incompetence. If this drug is not launched in some major market before Q4 2022…incompetence. Time is money and when it comes to GBM, there is no making up for lost lives and lost revenue.

There is still a chance that all or most of these things are addressed behind the scenes. Unfortunately, we retail investors are left to guess and speculate. This may be due to a grand plan coming to fruition, or it may be incompetence. We will soon find out which is true and what that means for patients. As an investor, I believe this asset has great value even if we are saddled with incompetence, it just wont be maximized for us in that case.

I agree with all of this 100%. I still fear that the holdup has nothing to do with publication and everything to do with waiting for confirmation from the FDA that they will accept the endpoint changes and sign off on the use of historical controls for this particular trial. And if that is the case, who knows when we will get data or be able to move forward with the BLA process.

This has been a long strange trip for sure.